About the Job

The Lab Operations Product Implementation Process Lead leads initiatives such as onboarding RUO products and Orthogonal Testing in the small-scale FMI Laboratory. Candidates should be highly motivated, able to think creatively, confident with multi-tasking and attentive to details. This role requires strong collaboration skills with stakeholders such as product development, process engineering, laboratory operations, quality assurance, and technology to ensure seamless implementation of new products. This position includes advanced troubleshooting, the tactical development and execution of implementation plans and training plans for new products. 

Key Responsibilities

• Lab Responsibilities 
  • Serve as a technical resource for Technicians and Technologists: Provide advanced troubleshooting support for RUO products Develop and execute training plans for RUO products 
  • Partner with clinical lab on training and competency assessment needs for work center. 
  • Partner with clinical lab on RUO processing needs and support the lab management with publishing the lab schedule for RUO processing. 
  • Lead process improvement initiatives 
  • Escalate issues and utilize established Quality Management System (QMS) for documenting these events, as required. 
• Product Implementation Responsibilities 
  • Partner with incubator lab to enable and implement assays from R&D into production 
  • Partner with vendors to install and implement new products into production 
  • Lead the evaluation of new instrumentation, new protocols or off the shelf tests for FMI Use. 
  • Ensure documentation requirements are met for new RUO assays and products. 
  • Guide a small team on executing assigned tasks and projects. 
  • Provide requirements to stakeholders for new assays, such as chemistry, hardware, and software. 
  • Strong collaboration access teams to execute on implementation of projects. 
  • Write documentation such as CQs, IQOQPQs, as required. 
  • Provide requirements for test cases for end to end testing for new products. 
  • Strong Problem Solving skills to creatively solution for challenges. 
  • Complete projects fitting of level of expertise and be able to deliver results with minimum guidance. •Liaise with other departments for updates on cross functional projects and initiatives. 
• Other Responsibilities 
  • Establish a deep understanding of the process to troubleshoot assays and instrumentation as needed. 
• Other duties as assigned. 

Qualifications

Basic Qualifications

• Bachelor’s degree in a biological, chemical, physical, or life science 
• 3+ years of relevant lab experience in a CLIA/CAP regulation-adherent lab 
• Certifications or licensure that is required by the state or county in which the job is posted 

Preferred Qualifications

• Familiarity with Laboratory Information Management System (LIMS) 
• A high level of experience and knowledge of FMI’s complex NGS laboratory 
• Quality management experience and experience with ensuring and maintaining integrity and quality of the lab (sample processing, equipment, QMS) 
• Experience writing SOPs and guidelines in the regulated environments referenced above 
• Previous experience in managing or leading a process 
• Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.) 
• Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point 
• Knowledge of and experience with Oncology 
• Ability to: 
  • work well under pressure while maintaining a professional demeanor 
  • prioritize and thoroughly follow up on assigned tasks 
  • handle multiple tasks at once and work in a fast-paced environment 
  • adapt to changing procedures, policies and work environment 
  • work within a highly complex clinical diagnostic laboratory environment within the presence of chemicals and reagents 
  • work any day and shift that the laboratory is operational 
• Understanding of HIPAA and importance of patient data privacy 
• Demonstrated integrity and a commitment to values held at FMI: patients, innovation, collaboration, and passion 

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